The following data is part of a premarket notification filed by Mano And Mano Proprietary Limited with the FDA for Mano And Mano Personal Lubricant.
| Device ID | K161585 |
| 510k Number | K161585 |
| Device Name: | Mano And Mano Personal Lubricant |
| Classification | Lubricant, Personal |
| Applicant | Mano And Mano Proprietary Limited 286 Chesterville Road Moorabbin, AU 3189 |
| Contact | Katrina Allen |
| Correspondent | Gary Mocnik ClinReg Consulting Services, Inc. 733 Bolsana Drive Laguna Beach, CA 92651 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-08 |
| Decision Date | 2016-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850017860131 | K161585 | 000 |
| 00850017860148 | K161585 | 000 |
| 00850017860001 | K161585 | 000 |
| 00850017860018 | K161585 | 000 |
| 00850017860025 | K161585 | 000 |
| 00850017860032 | K161585 | 000 |
| 00850017860049 | K161585 | 000 |
| 00850017860056 | K161585 | 000 |
| 00850017860063 | K161585 | 000 |
| 00850017860070 | K161585 | 000 |
| 00850017860087 | K161585 | 000 |
| 00850017860094 | K161585 | 000 |
| 00850017860100 | K161585 | 000 |
| 00850017860117 | K161585 | 000 |
| 00850017860124 | K161585 | 000 |
| 00850017860155 | K161585 | 000 |